On May 25, FDA issued warning letters to firms responsible for two popular flavored, disposable e-cigarette products—Shenzhen Innokin Technology Co. Ltd. who make Esco Bars products and Breeze Smoke, LLC who import and distribute Breeze products. These firms have been manufacturing, distributing, and/or importing unauthorized tobacco products in the United States.
According to the 2022 National Youth Tobacco Survey, over 55 percent of current youth e-cigarette users most commonly use a disposable e-cigarette product. Esco Bars and Breeze are presently among the most commonly sold brands of disposable products in the United States.
Today’s actions underscore FDA’s commitment to protecting youth against illegal flavored, disposable e-cigarette products. On May 12, FDA also issued an import alert for Esco Bars products. The import alert places these tobacco products on the red list, which allows FDA to refuse or detain the product at the time of entry and to prevent illegal products from being distributed in the U.S.
“The science clearly shows that a majority of youth who use e-cigarettes report that the products they are using are disposable and flavored” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “Given their appeal to youth, these products are a priority for FDA compliance and enforcement action.”
The e-cigarette firms that received warning letters today make, distribute, or import tobacco products that lack authorization from FDA, which is a prohibited act under the Federal Food, Drug, and Cosmetic (FD&C) Act. FDA generally sends warning letters the first time an investigation or inspection reveals a violation. A majority of recipients of warning letters correct the stated violation. However, failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties.
“We will continue to use the full scope of tools in our regulatory toolbox to make sure that those who make, distribute, or sell illegal e-cigarette products are held accountable,” said Dr. King. “Firms receiving a warning letter have 15 days to respond to FDA outlining how they will address the violation. If a firm doesn’t adequately address the violation, we have a bevy of enforcement actions at our disposal that potentially await them.”
To date, FDA has authorized 23 tobacco-flavored e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully sold in the U.S. The distribution or sale of unlawfully marketed products is subject to enforcement action.
FDA remains steadfast in its commitment to protecting youth from the harms of tobacco products by ensuring illegal products are not marketed, distributed, or sold. These efforts include ongoing surveillance of the marketplace to identify violative products, including e-cigarettes.
From January 2021 through May 19, 2023, FDA has issued more than 560 warning letters, filed ten civil money penalties, and filed six injunctions to firms marketing illegal e-cigarettes. All of these actions are part of FDA’s standing compliance and enforcement portfolio, and the latest counts of these actions will continue to be reported on a routine basis. FDA will continue to take action against anyone making, distributing, importing, or selling unauthorized e-cigarette products, especially those most used by youth.